The Route 92 Medical 070 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

Device Description

The Route 92 Medical 070 Access System is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, singlelumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical 070 Access System is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.

AI/ML Overview

This document describes the Route 92 Medical 070 Access System, a percutaneous catheter intended to facilitate the insertion and guidance of microcatheters in the neurovascular system. The provided text, K203043, is a 510(k) summary from the FDA, detailing the device's substantial equivalence to a predicate device based on non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "All samples met the pre-determined acceptance criteria" for each test. The actual numerical thresholds for these criteria are not explicitly stated in this document but are implied to be established standards for such medical devices.

Test	Test Method	Reported Device Performance
Biocompatibility
Cytotoxicity	ISO MEM Elution	The test article is non-cytotoxic.
Sensitization	ISO Guinea Pig Maximization Sensitization Test (Normal Saline and Sesame Oil)	The test article did not elicit a sensitization response.
Irritation	ISO Intracutaneous Reactivity (Normal Saline and Sesame Oil)	Requirements of the ISO intracutaneous reactivity test have been met for the test article.
Acute Systemic Toxicity	ISO Acute Systemic Injection (Normal Saline and Sesame Oil)	Requirements of the ISO acute systemic injection test have been met for the test article.
Pyrogen	Material Mediated Pyrogen (Normal Saline)	The test article is non-pyrogenic.
Hemocompatibility – Complement Activation	Complement Activation (SC5b-9)	The test article would not be expected to result in adverse effects in vivo.
Hemocompatibility – Partial Thromboplastin Time	Partial Thromboplastin Time	The test article is considered to be a non-activator of the intrinsic coagulation pathway.
Hemocompatibility – ASTM Hemolysis	ASTM Hemolysis	The test article is considered non-hemolytic.
Hemocompatibility – Thromboresistance	Thromboresistance	The test articles have similar thromboresistance characteristics as the control devices.
Performance Testing
Dimensional Verification	Device dimensions were measured to confirm conformance to the specifications.	PASS (All samples met the pre-determined acceptance criteria)
Tensile Strength	The tensile strength of the catheter sections and bonds was tested.	PASS (All samples met the pre-determined acceptance criteria)
Kink Resistance	Test specimen segments were formed into a defined bend diameter to evaluate kink resistance.	PASS (All samples met the pre-determined acceptance criteria)
Torsion Resistance	The test specimens were rotated to evaluate integrity after rotation.	PASS (All samples met the pre-determined acceptance criteria)
Tip Flexibility	Test specimens were tested for tip flexibility.	PASS (All samples met the pre-determined acceptance criteria)
Air Leakage	Tested per ISO 10555-1:2013 Annex D.	PASS (All samples met the pre-determined acceptance criteria)
Liquid Leakage / Static Burst	Tested per ISO 10555-1:2013 Annex C.	PASS (All samples met the pre-determined acceptance criteria)
Dynamic Burst	Mechanical integrity was maintained up to the specified pressures.	PASS (All samples met the pre-determined acceptance criteria)
Hydrophilic Coating Integrity	The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles.	PASS (All samples met the pre-determined acceptance criteria)
Particulate Recovery	After multiple insertion and withdrawal cycles, the effluent water rinsed and flushed from the devices and model was tested per USP <788>. Particulates were characterized for size ranges ≥10 um, ≥25 um, ≥50 µm, ≥100 µm, ≥200 µm, ≥500 µm and ≥1000 µm.	PASS (All samples met the pre-determined acceptance criteria)
Simulated Use Testing	Deliverability and compatibility with accessory devices was evaluated in a neurovascular model.	PASS (All samples met the pre-determined acceptance criteria)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document repeatedly states "All samples met the pre-determined acceptance criteria" but does not specify the exact number of samples used for each test set.
Data Provenance: The tests are non-clinical (laboratory/bench testing) and were conducted by the manufacturer (Route 92 Medical, Inc.) to demonstrate substantial equivalence. The country of origin of the data is not explicitly stated but is implicitly the United States, given the FDA submission. The data is prospective for the purpose of this 510(k) submission, as it was generated specifically to support the clearance of this device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Ground Truth Establishment: For non-clinical performance and biocompatibility testing of a medical device like this catheter, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM, USP) and engineering specifications. It's not based on expert consensus in the same way as, for example, image interpretation.
Experts: The document does not mention the use of human experts to establish ground truth for these non-clinical tests. The tests themselves provide the "ground truth" against the established quantitative criteria from the standards.

4. Adjudication Method

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or multi-reader reviews involving subjective assessments, especially for diagnostic devices. This is a non-clinical, bench-top testing summary. Therefore, an adjudication method as described is not applicable and was not used. The results are compared directly to predefined quantitative pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This device is a physical medical device (catheter system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone Performance

Yes, a standalone performance study was done. All the listed biocompatibility and performance tests are standalone evaluations of the device's physical and biological characteristics without human intervention in the test setup (beyond conducting the test itself). The device itself is not an AI algorithm, so the term "algorithm only" is not directly applicable, but the tests were "device only" performance assessments.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests is based on established industry standards and documented engineering specifications/acceptance criteria. These standards include:
- ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for biocompatibility.
- ISO 10555-1:2013: Intravascular Catheters - Sterile Single-Use Catheters - Part 1: General Requirements for Air and Liquid Leakage / Static Burst.
- USP <788>: Particulate Matter in Injections for particulate recovery.
- Generic acceptance criteria for mechanical properties (Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Dynamic Burst, Hydrophilic Coating Integrity, Dimensional Verification) which would be defined by the manufacturer based on expected performance and comparison to predicate devices, and internal design requirements.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI model requiring a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is a physical medical device, not an AI model.

In summary, the K203043 submission demonstrates the substantial equivalence of the Route 92 Medical 070 Access System through comprehensive non-clinical testing. The device met all pre-determined acceptance criteria based on established industry standards and internal specifications, confirming its safety and performance for its intended use.

Summary

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Build Correspondence

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November 11, 2020

Route 92 Medical, Inc. Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402

Re: K203043

Trade/Device Name: Route 92 Medical 070 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: October 2, 2020 Received: October 6, 2020

Dear Kirsten Valley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203043

Device Name Route 92 Medical 070 Access System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K203043 510(k) Summary

Sponsor:	Route 92 Medical, Inc.
	155 Bovet Road, Suite 100
	San Mateo, CA 94402
	Phone: 650-581-1179
Contact:	Kirsten Valley
Date Prepared:	November 10, 2020
Device Name:	Route 92 Medical 070 Access System
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter (Product Code QJP, 21 CFR870.1250)
Predicate Device:	Route 92 Medical 088 Access System, K201518

Device Description

Indications for Use

Comparison to the Predicate Device

The method of action, design, and materials of the Route 92 Medical 070 Access System are equivalent to the Predicate Device as shown in the following table.

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Attribute	Predicate DeviceRoute 92 Medical 088 Access System(K201518)	Subject DeviceRoute 92 Medical 070 Access System
Indicationsfor Use	The Route 92 Medical 088 AccessSystem, 143 cm, is indicated for usewith compatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem.	The Route 92 Medical 070 AccessSystem is indicated for use withcompatible guide catheters infacilitating the insertion and guidanceof microcatheters into a selectedblood vessel in the neurovascularsystem.
DeviceDescription	Sterile, single-use, variable stiffness,coil-reinforced catheter with proximalcontrol wire	Same
Targetedpopulation	Patients requiring use of amicrocatheter in the neurovascularsystem	Same
User	Physicians trained in neurovascularinterventional techniques	Same
AnatomicalSites	Neurovasculature only	Same
Materials	Polymers and metals commonly usedin the manufacture of medical devices	Same
Sterilization	100% ethylene oxide	Same
Shelf Life	8 months	Same
Support Catheter
InnerDiameter	0.088"	0.070"
OuterDiameter	Distal: 0.101"Proximal: 0.105"	Distal: 0.082"Proximal: 0.087"
Length	143 cm	142 cm
Delivery Catheter
InnerDiameter	0.019"	Same
OuterDiameter	Distal: 0.080"Proximal: 0.062"	0.062"
Length	151 cm	Same

Non-Clinical Testing Biocompatibility Testing

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The Route 92 Medical 070 Access System is constructed using the same materials as the predicate device. All patient contacting components have been evaluated for biocompatibility in accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Route 92 Medical 070 Access System is classified per ISO 10993-1 as externally communicating with limited circulating blood contact (<24 hours). A summary of the biocompatibility testing is provided below.

Test	Conclusions
Cytotoxicity – ISO MEM Elution	The test article is non-cytotoxic.
Sensitization – ISO Guinea PigMaximization Sensitization Test (NormalSaline and Sesame Oil)	The test article did not elicit a sensitization response.
Irritation – ISO Intracutaneous Reactivity(Normal Saline and Sesame Oil)	Requirements of the ISO intracutaneous reactivity test have been met for the test article.
Acute Systemic Toxicity – ISO AcuteSystemic Injection (Normal Saline andSesame Oil)	Requirements of the ISO acute systemic injection test have been met for the test article.
Pyrogen – Material Mediated Pyrogen(Normal Saline)	The test article is non-pyrogenic.
Hemocompatibility – ComplementActivation (SC5b-9)	The test article would not be expected to result in adverse effects in vivo.
Hemocompatibility – Partial ThromboplastinTime	The test article is considered to be a non-activator of the intrinsic coagulation pathway.
Hemocompatibility – ASTM Hemolysis	The test article is considered non-hemolytic.
Hemocompatibility – Thromboresistance	The test articles have similar thromboresistance characteristics as the control devices.

Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical 070 Access System is suitable for its intended use.

Test	Test Method	Results
DimensionalVerification	Device dimensions were measuredto confirm conformance to thespecifications	PASSAll samples met the pre-determinedacceptance criteria
Tensile Strength	The tensile strength of the cathetersections and bonds was tested	PASSAll samples met the pre-determinedacceptance criteria
Test	Test Method	Results
Kink Resistance	Test specimen segments wereformed into a defined benddiameter to evaluate kinkresistance	PASSAll samples met the pre-determinedacceptance criteria
TorsionResistance	The test specimens were rotated toevaluate integrity after rotation	PASSAll samples met the pre-determinedacceptance criteria
Tip Flexibility	Test specimens were tested for tipflexibility	PASSAll samples met the pre-determinedacceptance criteria
Air Leakage	Tested per ISO 10555-1:2013Annex D.	PASSAll samples met the pre-determinedacceptance criteria
Liquid Leakage /Static Burst	Tested per ISO 10555-1:2013Annex C.	PASSAll samples met the pre-determinedacceptance criteria
Dynamic Burst	Mechanical integrity wasmaintained up to the specifiedpressures	PASSAll samples met the pre-determinedacceptance criteria
HydrophilicCoating Integrity	The integrity of the hydrophiliccoating was evaluated aftermultiple insertion and withdrawalcycles.	PASSAll samples met the pre-determinedacceptance criteria
ParticulateRecovery	After multiple insertion andwithdrawal cycles, the effluentwater rinsed and flushed from thedevices and model was tested perUSP <788>. Particulates werecharacterized for size ranges ≥10um, ≥25 um, ≥50 µm, ≥100 µm,≥200 µm, ≥500 µm and ≥1000 µm	PASSAll samples met the pre-determinedacceptance criteria
Simulated UseTesting	Deliverability and compatibilitywith accessory devices wasevaluated in a neurovascular model	PASSAll samples met the pre-determinedacceptance criteria

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Substantial Equivalence

The Route 92 Medical 070 Access System has the same intended use, the same technological characteristics and same method of action as the predicate device. The successful completion of

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biocompatibility testing and performance testing demonstrates that the Route 92 Medical 070 Access System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).